© CDISC 2011

Joint Initiative Council

18 October 2011

Bron Kisler, VP, Strategic Initiatives, Current JIC Leader

Rebecca D. Kush, PhD, President and CEO, CDISC

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CDISC Strategy

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World Standards Day

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Internationalstandards

Creating CONFIDENCEGlobally

14 October 2011

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CDISC Vision: Informing patient care and safety through higher quality medical research

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CDISC Strategic Goals 2012 ~ 2015

# 1 Core Standards for Aggregate Data Analysis •Achieve significant progress in the use of core CDISC standards to allow scientifically sound data aggregation and support secondary uses of research data for the purposes of scientific investigation and comparative effectiveness.

Examples:•FDA and NCI are developing a Clinical Trial Repository (CTR); the model will be open. It is based on BRIDG and SDTM.•Critical Path Institute is developing open, shared databases through Coalition Against Major Diseases (CAMD); based on SDTM, developing CDASH.

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© CDISC 2011

Public Release of Alzheimer's Clinical Trial Data By Pharmaceutical Researchers

PR Newswire

WASHINGTON, 11 June 2010

First Combined Pharmaceutical Trial Data on Neuro-degenerative Diseases; Shared Resource from Unique Public-Private Partnership Will Help Accelerate Alzheimer's, Parkinson's, and Other Brain Disease Research

WASHINGTON, June 11 /PRNewswire-USNewswire/ -- A new database of more than 4,000 Alzheimer's disease patients who have participated in 11 industry-sponsored clinical trials will be released today by the Coalition Against Major Diseases (CAMD).  This is the first database of combined clinical trials to be openly shared by pharmaceutical companies and made available to qualified researchers around the world.  

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Initial database required mapping to a standard (CDISC); can now be leveragedto collect data using the standard.

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CDISC Strategic Goals 2012 ~ 2015# 2 Healthcare/Research Data Interoperability•Achieve significant progress in enabling interoperability between clinical care and clinical research, and explore expansion from bench to bedside•By linking these realms through standards, CDISC will follow its principle of collecting data once, using it many times, so that research informs healthcare, and healthcare informs research.

Examples:•CDISC-IHE Integration Profiles, e.g. RFD•EHR for Clinical Research Functional Profile•IMI EHR4CR and Interoperability Showcases

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© CDISC 2011

CDISC Strategic Goals 2012 ~ 2015

# 3 Semantics•Develop CDISC SHARE, a global, accessible, electronic library for CDISC content. •CDISC SHARE will enable precise and standardized data element definitions and richer metadata that can be reused within applications and across studies to improve biomedical research and its link with healthcare.

Examples:•SHARE = Shared Health and Research Electronic Library; stakeholder survey of > 70 participants agreed on value.•Concepts for research developed; infrastructure ‘on hold’ due to NCI evaluation…seeking global solution.

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© CDISC 2011

CDISC Strategic Goals 2012 ~ 2015

• # 4 Therapeutic/Specialty Area Standards• Expedite the development and rollout of new

therapeutic-area or specialty standards while continuing to refine, support and educate on existing standards.

• Incorporating therapeutic area needs into existing CDISC standards will ensure consistency in data capture and analysis for therapeutic endpoints and other disease-specific data elements to address efficacy and other aspects of trials.

Examples: Alzheimer’s disease…..

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© CDISC 2011

Now published….

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CDISC Alzheimer’s Disease SDTM User Guide (Version 1.0) ©

See also “Questionnaires” on the CDISC website under Standards & Innovations.

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CDISC Strategic Goals 2012 ~ 2015

# 5 Ensure CDISC Infrastructure to Support the first four goals!

Standards Maintenance Legal/HR/Accounting Education Alliances Member Relations Public Relations

Communications

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© CDISC 2011

Recent Lessons from the HIT Standards Committee Chairs

• We need to balance innovation vs. specification; don’t ‘constrain’ but rather define what can be supported.

• Learn from others who have pushed the envelope.

• In many countries, developers cannot articulate a standard until it is perfect; since it is never perfect, it is never articulated.

• One way of thinking of a definition for standards is that they are ‘implementable’ and that their success is measured by adoption vs. volumes of documentation:

“Standards aren’t created; they are adopted.”

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Quotes from HITSC Chairs, Jonathan Perlin and John HalamkaCDISC Blog and eNews 7 October 2011

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CDISC Operational Direction

a) managing a robust, quality process that is far more streamlined than the one we used for developing our core standards;

b) thinking outside of the box in order to develop such a process and accompanying tools such as SHARE;

c) linking our work with healthcare and genomics standards;

d) re-engaging our CDISC volunteers and engaging new volunteers from around the globe;

e) not expecting a perfectly complete standard before it is made available for comment, testing, iteration, improvement and gradually broader adoption;

f) build upon our core standards;

g) increase adoption.

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